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NCT Number: NCT06577883

Next Generation Chest X-Ray Tomosynthesis for Screening of Lung Cancer

The goal of this observational clinical trial is to learn if chest tomosynthesis is a potential alternative to computed tomography for the detection of lung cancer. It will also develop artificial intelligence tools to aid in the diagnosis of lung cancer on chest tomosynthesis images. The main questions it aims to answer are:

* What is the accuracy of chest X-ray tomosynthesis in diagnosing lung cancer in a population of individuals undergoing lung cancer screening or evaluation of a suspicious lung nodule? * Can artificial intelligence help us detect lung cancer on chest tomosynthesis images?

Researchers will compare chest tomosynthesis images to computed tomography scans for each participant to see how they compare in diagnosing lung cancer.

Participants will a chest tomosynthesis scan in addition to their routine clinical computed tomography scan.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California San Diego

San Diego, California, 92093, United States

Location status: Recruiting

Location contact

Alexander Cypro, MD

CONTACT

[email protected]

858-246-2196

About this study

Lung cancer remains the most common cause of cancer death in the United States for which low-dose CT has proven benefit for early detection and survival from lung cancer. However, adoption remains low. Furthermore, >95% of nodules detected on low-dose CT, especially those smaller than 6 mm, do not represent cancer. We have partnered to develop a novel chest x-ray tomosynthesis (CXRT) device with the hypothesis that this device might be an alternative to CT for detection of lung cancer. We seek to recruit a cohort of patients to undergo CXRT, composed of patients concurrently undergoing lung cancer screening CT and diagnostic CT for new lung cancer. We will determine the effectiveness of CXRT for detecting lung cancer in this population, evaluating its sensitivity and specificity for detecting cancer and lung nodules at multiple size thresholds in a multireader study. We will additionally develop artificial intelligence algorithms and evaluate their efficacy to further enhance cancer detection.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • undergoing lung cancer screening
  • undergoing evaluation of suspicious pulmonary nodule
  • newly diagnosed lung cancer

Exclusion criteria

  • prior history of lung cancer treatment

Treatment and study plan

Chest X-ray Tomosynthesis

Diagnostic Test

An imaging device that uses X-rays projected from multiple angles to reconstruct a three-dimensional images of the chest

Other names: CXRT

Primary outcomes

  1. Chest X-ray tomosynthesis detection of lung cancer

    Time frame: through 12/31/2026

    Diagnostic accuracy of chest tomosynthesis in identifying biopsy-proven lung cancer

Secondary outcomes

  1. Chest X-ray tomosynthesis detection of suspicious nodules

    Time frame: through 12/31/2026

    Diagnostic accuracy of chest tomosynthesis in identifying pulmonary nodules seen on chest CT at multiple minimum size thresholds: 6-mm, 8-mm, 10-mm

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander Cypro, MD

CONTACT

[email protected]

858-2462196

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • AIxSCAN, Inc.

Registry information

Official study title

Chest X-ray Tomosynthesis for Detection of Lung Cancer and Lung Disease

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Aug 29, 2024
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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